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NCT Number: NCT00385541

Comparison of Side Effects of Morphine and Hydromorphone Patient-Controlled Analgesia (PCA)

Both morphine and hydromorphone are pain medications commonly used after surgery. It is thought at the institution that hydromorphone causes less side effects but this has not been studied. The study proposes to treat the patients with either morphine or hydromorphone and determine how much nausea, vomiting, and itching they have with each drug

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Key information

Conditions

Post Operative Pain Nausea Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Pruritus Signs and Symptoms Signs and Symptoms, Digestive Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Vomiting

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Columbia Presbyterian Hospital

New York, 10032, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients scheduled for abdominal surgery requiring post-operative PCA
  • ASA = I or II

Exclusion criteria

  • preoperative pain or use of pain medication
  • narcotic allergy
  • morbid obesity (Body Mass Index > 30)
  • diagnosis of sleep apnea
  • hepatic or renal disease
  • use of medications that would affect narcotic pharmacodynamics
  • preoperative nausea, vomiting, or pruritis
  • diagnosis of alcoholism

Treatment and study plan

Morphine PCA

Drug

Morphine 1mg/mL, dose 1mL, lockout 6 minutes, max 10mL

Other names: Astramorph PF, Duramorph, Infumorph

Hydromorphone PCA

Drug

hydromorphone PCA 0.2mg/lml, dose 1ml, lockout 6min, max 10ml

Other names: Dilaudid

Primary outcomes

  1. Nausea Assessment by Patient

    Time frame: 1 hour after surgery, 8 hours after surgery

    Nausea scale range: (0 = none, 10 = the worst), ordinal.

Secondary outcomes

  1. Mean Score on the Numeric Rating Scare (NRS) Pruritus Scale

    Time frame: 1 hour after surgery, 8 hours after surgery

    The NRS Pruritus Scale was used to measure magnitude of pruritus (0 = none, 10 = the worst).

  2. Pain Assessment by Patient

    Time frame: 1 hour after surgery, 8 hours after surgery

    Numeric Rating Scale for Pain: (0 = none, 10 = the worst), ordinal.

  3. The Number of Patients Who Vomited

    Time frame: 1 hour after surgery, 8 hours after surgery

  4. Mean Score on the Ramsey Scale of Sedation

    Time frame: 1 hour after surgery, 8 hours after surgery

    The Ramsey scale is used as a measure of sedation from 1 (the patient in anxious and agitated) to 6 (the patient exhibits no response).

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

The Comparison of Morphine and Hydromorphone Patient-Controlled Analgesia

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Oct 9, 2006
Registry last updated
Aug 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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